Coated looped suture

ABSTRACT

A suture including a reinforced loop is described herein. The suture includes an elongate body including a proximal section and a distal section, wherein the distal section includes first and second overlapping sections and a loop. A polymeric coating is positioned on at least a portion of the distal section to reinforce the loop.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional application of U.S. patentapplication Ser. No. 13/045,618, filed on Mar. 11, 2011, which claimsthe benefit of and priority to U.S. Provisional Application Ser. No.61/322,106 filed on Apr. 8, 2010, the entire contents of each of whichare incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a suture having a loop. Moreparticularly, the present disclosure relates to a looped suture having apolymeric coating which reinforces the loop.

2. Background of Related Art

Sutures including loops formed therein are known. A loop formed in asuture during manufacture may be used to secure the suture to tissue. Inthis manner, once the non-looped end of the suture is inserted throughtissue, that end may be threaded through the loop to form a slipknot-like configuration that may be tied to secure tissue. In anotherapplication, a loop may be formed in a suture in place of a knot. Thisrequires the use of a handheld instrument that may be brought into anoperating room.

Regardless of the reason for forming the loop, when a loop is formed ina suture, whether using adhesive, heat or ultrasonic energy, the loopmay be under an inherent stress originating from the hairpin turn thesuture makes in forming the loop. In the event that the suture loop isused to secure tissue, the holding power of the loop may be placed underincreased stress while the tissue is healing. This increased stressapplied to the loop may result in separation or the pulling apart of theloop.

Therefore, it would be beneficial to have a looped suture of enhancedloop stability.

SUMMARY

A suture including a loop is provided. The suture includes an elongatebody including a proximal section and a distal section, wherein thedistal section of the elongate body includes first and secondoverlapping sections and a loop. A distal aperture may be defined by theloop. A polymeric coating is positioned on at least a portion of thedistal section to reinforce the loop.

The overlapping sections may be secured together to form the loop by atleast one method selected from the group consisting of glues, adhesives,solvents, heat and ultrasonic energy. The loop may be sized anddimensioned to receive a length of the elongate body. The loop may besized and dimensioned to receive a surgical needle.

In embodiments, the polymeric coating may be positioned on the first andsecond overlapping sections. In other embodiments, the polymeric coatingmay be positioned on at least a portion of the loop. In still otherembodiments, the polymeric coating may be positioned across the distalaperture. In yet another embodiment, the polymeric coating may bepositioned on the entire distal portion of the suture.

Also provided is a method of using a looped suture including a polymericcoating to reinforce the loop. The method includes the steps ofproviding a suture including an elongate body, and a loop formed on adistal end of the elongated body, wherein at least a portion of thedistal end includes a polymeric coating to reinforce the loop, insertinga proximal end of the elongate body into tissue, and pulling theelongate body through the tissue until the loop engages the tissue.

The method further includes the step of inserting the proximal end ofthe elongate body through the loop. The suture may include a needle onthe proximal end of the elongate body. The method may also include thestep of tensioning the proximal end of the elongate body through theloop until the tissue is retained within the suture.

In another embodiment, methods of forming a reinforced looped suture arealso described. The methods may include the steps of providing a suturehaving an elongate body including a proximal section and a distalsection, wherein the distal section includes first and secondoverlapping sections, and a loop, and applying a polymeric coating to atleast a portion of the distal section of the elongate body to reinforcethe loop. In embodiments, the suture provided may also include a distalaperture defined by the loop. In embodiments, the polymeric coating mayapplied to at least one portion of the distal section including thefirst and second overlapping sections, the loop, the distal aperture andcombinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiment(s) given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1A is a side view of a looped suture in accordance with oneembodiment of the present disclosure;

FIG. 1B is a cross-sectional end view of the looped suture taken alongline B-B of FIG. 1A;

FIGS. 2A-2F are perspective views of a suture having a circular (FIG.2A), oval (FIG. 2B), rectangular (square) (FIG. 2C), flat (FIG. 2D),octagonal (FIG. 2E), and rectangular (FIG. 2F) cross-sectional profiles;

FIG. 3 is a side view of a looped suture in accordance with oneembodiment of the present disclosure;

FIG. 4 is a side view of a looped suture in accordance with an alternateembodiment of the present disclosure;

FIG. 5 is a side view of a looped suture in accordance with anotherembodiment of the present disclosure;

FIG. 6 is a side view of a looped suture in accordance with yet anotherembodiment of the present disclosure;

FIGS. 7A-7C are views of an alternate embodiment of a looped suture ofthe present disclosure;

FIGS. 8A-8C are views of yet another embodiment of a looped suture ofthe present disclosure; and

FIGS. 9A-9C are views of still another embodiment of a looped suture ofthe present disclosure.

DETAILED DESCRIPTION

As shown in FIG. 1A, looped suture 10 includes elongate body 11 havingproximal end 10 a and distal end 10 b. Proximal end 11 a of elongatebody 11 may include one or more suture needles (not shown). Distal end11 b of elongate body 11 includes first section 13 overlaying secondsection 14 to form loop 12. The adjacent surfaces of first and secondsections 13, 14 form a joined segment or joint 15. Distal aperture 18 isdefined within loop 12 which may form a substantially teardrop shape ofany suitable size. In one embodiment, loop 12 is sized to receiveproximal end 11 a of looped suture 10. Polymeric coating 20 is shownpositioned on at least a portion of distal end 11 b to reinforce loop12. In embodiments, polymeric coating 20 may be positioned on both firstand second overlapping sections 13, 14 to reinforce joint 15 and loop12, as depicted in FIG. 1B.

Although shown in FIGS. 1A and 1B as having a circular cross-sectionalgeometry, the cross-sectional geometry of elongate body 11 may be of anysuitable shape. For example, FIGS. 2A-2F illustrate cross-sectionalviews of alternative embodiments of the various cross-sectionalgeometries of elongate body 11, namely, round (FIG. 2A), elliptical(FIG. 2B), square (FIG. 2C), flat (FIG. 2D), octagonal (FIG. 2E), andrectangular (FIG. 2F).

Sutures described herein may be formed from any sterilizablebiocompatible material that has suitable physical properties for theintended use of the suture. The sutures described herein may bemonofilaments or multifilaments sutures. The biocompatible materials mayinclude biocompatible polymers, such as homopolymers or copolymers,including random copolymers, block copolymers, or graft copolymers.Biocompatible polymers may be a linear polymers, branched polymers ordendrimers.

Suitable polymers which may be used to construct sutures disclosedherein include, for example, synthetic materials, natural materials(e.g., biological) and combinations thereof. Suitable materials include,polyolefins such as polyethylene (including ultra high molecular weightpolyethylene) and polypropylene including atactic, isotactic,syndiotactic, and blends thereof; polyethylene glycols; polyethyleneoxides; ultra high molecular weight polyethylene; copolymers ofpolyethylene and polypropylene; polyisobutylene and ethylene-alphaolefin copolymers; fluorinated polyolefins such as fluoroethylenes,fluoropropylenes, fluoroPEGSs, and polytetrafluoroethylene; polyamidessuch as nylon, Nylon 6, Nylon 6,6, Nylon 6,10, Nylon 11, Nylon 12, andpolycaprolactam; polyamines; polyimines; polyesters such as polyethyleneterephthalate, polyethylene naphthalate, polytrimethylene terephthalate,and polybutylene terephthalate; polyethers; polybutester;polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylicpolymers; methacrylics; vinyl halide polymers and copolymers, such aspolyvinyl chloride; polyvinyl alcohols; polyvinyl ethers such aspolyvinyl methyl ether; polyvinylidene halides such as polyvinylidenefluoride and polyvinylidene chloride; polychlorofluoroethylene;polyacrylonitrile; polyaryletherketones; polyvinyl ketones; polyvinylaromatics such as polystyrene; polyvinyl esters such as polyvinylacetate; copolymers of vinyl monomers with each other and olefins, suchas ethylene-methyl methacrylate copolymers; acrylonitrile-styrenecopolymers; ABS resins; ethylene-vinyl acetate copolymers; alkyd resins;polycarbonates; polyoxymethylenes; polyphosphazine; polyimides; epoxyresins; aramids; rayon; rayon-triacetate; spandex; silicones; andcopolymers and combinations thereof. Additionally, non-biodegradablepolymers and monomers may be combined with each other to create a coreof a fiber, for example a fiber possessing a core-sheath configuration.

Suitable bioabsorbable polymers may comprise implants of the presentdisclosure include, but are not limited to polymers selected from thegroup consisting of aliphatic polyesters; polyamides; polyamines;polyalkylene oxalates; poly(anhydrides); polyamidoesters;copoly(ether-esters); poly(carbonates) including tyrosine derivedcarbonates; poly(hydroxyalkanoates) such as poly(hydroxybutyric acid),poly(hydroxyvaleric acid), and poly(hydroxybutyrate); polyimidecarbonates; poly(imino carbonates) such as such as poly (bisphenolA-iminocarbonate and the like); polyorthoesters; polyoxaesters includingthose containing amine groups; polyphosphazenes; poly (propylenefumarates); polyurethanes; polymer drugs such as polydiflunisol,polyaspirin, and protein therapeutics; biologically modified (e.g.,protein, peptide)bioabsorbable polymers; and copolymers, blockcopolymers, homopolymers, blends, and combinations thereof.

More specifically, for the purpose of this invention, aliphaticpolyesters include, but are not limited to, homopolymers and copolymersof lactide (including lactic acid, D-,L- and meso lactide); glycolide(including glycolic acid); epsilon-caprolactone, p-dioxanone(1,4-dioxan-2-one); trimethylene carbonate (1,3-dioxan-2-one); alkylderivatives of trimethylene carbonate; Δ-valerolactone; β-butyrolactone;γ-butyrolactone; {acute over (ε)}-decalactone; hydroxybutyrate;hydroxyvalerate; 1,4-dioxepan-2-one (including its dimer1,5,8,12-tetraoxacyclotetradecane-7,14-dione); 1,5-dioxepan-2-one;6,6-dimethyl-1,4-dioxan-2-one; 2,5-diketomorpholine; pivalolactone; α,αdiethylpropiolactone; ethylene carbonate; ethylene oxalate;3-methyl-1,4-dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-dione;6,8-dioxabicycloctane-7-one; and polymer blends and copolymers thereof.

Other suitable biodegradable polymers include but are not limited topoly(amino acids) including proteins such as collagen (I, II and III),elastin, fibrin, fibrinogen, silk, and albumin; peptides includingsequences for laminin and fibronectin (RGD); polysaccharides such ashyaluronic acid (HA), dextran, alginate, chitin, chitosan, andcellulose; glycosaminoglycan; gut; and combinations thereof. Collagen asused herein includes natural collagen such as animal derived collagen,gelatinized collagen, or synthetic collagen such as human or bacterialrecombinant collagen.

The looped sutures may be formed using any technique within the purviewof those skilled in the art, such as, for example, extrusion, molding,casting and/or spinning. In some embodiments, the sutures may include ayarn made of more than one filament, which may contain multiplefilaments of the same or different materials. Where the suture is madeof multiple filaments, the suture may be made using any known techniquesuch as, for example, braiding, weaving or knitting. The sutures mayalso be drawn, oriented, annealed, calendared, crinkled, twisted,commingled or air entangled to form yarns as part of the suture formingprocess. In one embodiment, a multifilament suture may be produced bybraiding. The braiding may be done by any method within the purview ofthose skilled in the art.

Suture 10 includes loop 12 on distal portion 11 b of elongate body 11.In embodiments, loop 12 may be formed during the formation of suture 10.In embodiments, loop 12 may be formed after the formation of suture 10.

In embodiments, loop 12 is formed by first and second sections 13, 14forming joint 15 on distal section 11 b of elongate body 11. First andsecond sections 13, 14 may form joint 15 using any suitable method knownthose skilled in the art. In one embodiment, first and second sections13, 14 of elongate body 11 are welded together. In this manner, firstand second sections 13, 14 of elongate body 11 are locally heated untileach fuses to form joint 15. Various types of energy may be used tolocally heat first and second sections 13, 14 to form joint 15,including, RF, ultrasonic, laser, electrical arc discharge, and thermal.Alternatively, first and second sections 13, 14 of elongate body 11 maybe joined using glue, epoxy or other adhesive.

As depicted in FIG. 1A, polymeric coating 20 may be positioned on atleast a portion of first and second sections 13, 14 of distal end 11 bof elongate body 11 to reinforce loop 12. Polymeric coating 20 may beformed from any biocompatible polymeric material capable of maintainingthe loop formation or enhancing the holding power of the loop. Someexamples of useful biocompatible materials used to form polymericcoating 20 include, but are not meant to be limited to: polylactic acids(PLA); polyglycolic acids (PGA); polylactide-co-glycolide copolymers(PLGA); polytrimethylene carbonate (PTMC); poly-{acute over(.epsilon.)}-caprolactone (PCL); poly-dioxanone (PDO);polyhydroxyalkanoates such as polyhydroxybutyrate (P3HB, P4HB),polyhydroxyvalerate (PHV), poly(3-hydroxybutyrate-co-3-hydroxyvalerate)(PHBV), polyhydroxyoctanoate (PHO), and polyhydroxyhexanoate (PHH);polyphosphazenes; polypropylene fumarates; polyanhydrides;polyorthoesters; polyimides; perfluoroalkoxy polymers (PFAs); florinatedethylene/propylene copolymers (FEP); polyanhydride esters; polyurethanesincluding polyether urethanes, polyester urethanes, polycarbonateurethanes, polyether ureas, polyester ureas, polycarbonate ureas andcombinations thereof, polysaccharides including cellulose,carboxymethylcellulose, chitosan, chitin, alginate, hyaluronic acid,fucans, and dextran; soybean protein; polyethylene-lactone copolymers;polyethylene-polyorthoester copolymers; polymer drugs; syntheticmaterials including hydrophilic vinyl polymers, phosphoryl cholines,hydroxamates, vinyl furanones, quarternary ammoniums, and alkyleneoxides; biopolymers made from collagen, gelatin, elastin, keratin,fibrin, thrombin, and the like; and blends, copolymers, homopolymers,and combinations thereof.

In embodiments, the biocompatible materials used to form polymericcoating 20 may be combined with a solvent to form a liquid polymercomposition prior to being applied to distal end 11 b of elongate body11 of suture 10. The liquid polymer composition may be a solution,suspension, emulsion dispersion, and the like. In embodiments, theliquid polymer composition may be a solution. The polymer solution mayinclude from about 0.1% to about 30% polymeric material by weight and atleast one solvent. Any variety of solvents may be suitable for formingthe polymer solution. Examples of suitable solvents include but are notlimited to at least one of the following: pentane, cyclopentane, hexane,cyclohexane, benzene, toluene, xylene, mesitylene, 1,4-dioxane,chloroform, diethyl ether, dichloromethane, tetrahydrofuran,1,1,2-trichloroethane, trifluoroethanol, methyl acetate, ethyl acetate,amyl acetate, acetone, dimethylformamide, acetonitrile,dimethylsulfoxide, formic acid, n-butanol, isopropanol, ethanol,n-propronal, methanol, acetic acid, water, methylene chloride,cyclohexanone, ethyl formate, 2,2,2-trifluoroethanol,2,2,3,3-tetrafluoro-1-propanol, 1,3-difluoro-2-propanol,1,1,1,3,3,3-hexafluoro-2-methyl-2-propanol,1,1,1,3,3,3-hexafluoro-2-propanol, 2,2,3,3,3-pentafluoro-1-propanol,nitroethane and combinations thereof.

In addition, polymer solutions may include at least one optionalingredient such as emulsifiers, viscosity enhancers, dyes, pigments,fragrances, pH modifiers, bioactive agent, wetting agent, plasticizers,antioxidants, and the like.

Alternatively, neat monomers, prepolymers or solutions of these,prepolymers hereon, can be used to form the polymeric coatings in situ.These prepolymers may be polymerized or crosslinked to form the finalcoating. Examples of monomers suitable for this application includecyanoacrylates, methyl methacrylate, methacrylate functional siliconeoligomers, low Tg acrylates, acrylate or methacrylate functionalpolyurethanes, n-vinyl pyrrolidone (NVP), acrylic acid (AA), methacrylicacid (MAA), 2-hydroxyethyl methacrylate (HEMA),2-acrylamido-2-methyl-1-propanesulfonic acid (AMPS),2-(Dimethylamino)ethyl methacrylate (DMAEMA),n-(tris(hydroxymethyl)methyl)acrylamide (Tris acryl), acryl amide,2-(methacryloyloxy)ethyl succinate,[2-(methacryloyloxy)ethyl]trimethylammonium methyl sulfate, and mixturesthereof. Crosslinking agents include dietheyleneglycol diacrylate,ethylene glycol dimethacrylate, 1,3-divinyltetramethyldisiloxane,divinyl benzene, and the like. The polymerization may be initiated withmoisture in the case of cyanoacrylate. The polymerization may beinitiated using heat sensitive initiators such as4,4′-azobis(4-cyanovaleric acid) (ACVA), 2,2′-azobisisobutyronitrile(AIBN), 2,T-azobis(2-methylproprionamidine) dihydrochloride (AMPA),benzoyl peroxide (BPO) and the like. More preferentially, thepolymerization may be initiated using light sensitive initiators such asbenzophenone (BP), methylbenzoylformate (MBF),2-benzyl-2-(dimethylamino)-4′-morpholinobutyrophenone (BDMB),2,2′-dimethoxy-2-phenyl acetophenone (DMPA),1-[1-(2-hydroxyethoxy)phenyl]-2-hydroxy-2-methyl-1-propan-1-one, and thelike. In other embodiments, prepolymers such as B-staged polyurethanes,2 part silicones and the like, may used to form the coating in situ. Thecoating is then fully cured using heat, light, or moisture depending onthe underlying chemistry.

The polymer coating may be applied to the distal section of the sutureusing any suitable method including spraying, dipping, brushing,rolling, wiping, painting, extruding, ultrasonics, and the like. Inembodiments, the looped suture may be dipped into a polymer solution. Insome embodiments, the polymer solution may be sprayed onto the loopedsuture.

The polymer solution may be applied to any portion of the distal end ofthe suture suitable to reinforce the loop. Following the application ofthe solution to the suture, the sutures may be allowed to dry using anysuitable drying method. Some non-limiting examples include drying underambient conditions, within an oven, under vacuum, or forced air.Solvents having a lower boiling point may dry faster. The entire distalsection of the elongate body may be dipped into the polymer solution andallowed to dry to form a polymeric coating which is positioned on theentire distal portion of the suture including both the loop and thefirst and second overlapping sections.

As depicted in FIG. 3, suture 310 includes elongate body 311 havingdistal end 311 b which includes first section 313 overlaying secondsection 314 to form loop 312 (phantom). Polymeric coating 320 ispositioned on loop 312 and a portion of first and second overlappingsections 313, 314. Distal aperture 318 is defined within loop 312 whichallows proximal end 311 a of suture 310 to pass through distal aperture318 without passing through polymeric coating 320. In some embodiments,distal aperture may be created through the use of a punch (not shown).

In some embodiments, as shown in FIG. 4, polymeric coating 420 ispositioned along loop 412 (phantom) and across distal aperture 418(phantom). In such embodiments, polymeric coating 420 may form a film orweb of sufficient thickness and/or elasticity to span the opening ofdistal aperture 418. In embodiments, proximal end 411 a may pierce theweb of polymeric coating 420 when passed through distal aperture 418 toclose wound tissue. In embodiments, polymeric coating 420 may completelycover distal end 411 b of elongate body 411, including first and secondoverlapping sections 413, 414, joint 415, loop 412, and distal aperture418.

Alternatively, as shown in FIG. 5, polymeric coating 520 may bepositioned along only a portion of loop 512 and across only a portion ofdistal aperture 518. In such embodiments, a portion of distal aperture518 remains open for passage of proximal section 511 a of suture 510.First and second overlapping sections 513, 514 and joint 515 of elongatebody 511 may not include polymeric coating 520. In some embodiments,polymeric coating 520 may include coating aperture 522 which may alsoallow for the passage of proximal section 511 a of suture 510. Coatingaperture 522 is shown as an opening created in the web of polymercoating 520 which spans distal aperture 518. Such an opening may beformed during the manufacturing of the coated loop suture or may beformed after being pierced with proximal end 511 a or surgical needle(not shown) attached to proximal end 511 a.

Turning now to FIG. 6, suture 610 may include barbs 630 and/or multiplepolymeric coatings, i.e., first polymeric coating 620 a and secondpolymeric coating 620 b. It is envisioned that barbs 630 may be formedin suture 610 before or after the application of polymeric coatings 620a and 620 b. First polymeric coating 620 a may be positioned along onlya portion of loop 612 and across only a portion of distal aperture 618.As shown, first polymeric coating 622 a includes a plurality of coatingapertures 622 a, 622 b, 622 c. Second polymeric coating 620 b may bepositioned on a different section of distal end 611 b and as shown ispositioned on a portion of first and second overlapping sections 613,614.

Barbs 630 may be arranged in any suitable pattern, for example, helical,linear, or randomly spaced. The pattern may be symmetrical orasymmetrical. The number, configuration, spacing and surface area ofbarbs 630 may vary depending upon the tissue in which suture 610 isused, as well as the composition and geometry of the material ofelongate body 611. Additionally, the proportions of barbs 630 may remainrelatively constant while the overall length of barbs 630 and thespacing of barbs 630 may be determined by the tissue being connected.For example, if suture 610 is to be used to connect the edges of a woundin skin or tendon, barbs 630 may be made relatively short and more rigidto facilitate entry into this rather firm tissue. Alternatively, ifsuture 610 is intended for use in fatty tissue, which is relativelysoft, barbs 630 may be made longer and spaced further apart to increasethe ability of suture 610 to grip the soft tissue.

The surface area of barbs 630 may also vary. For example, fuller-tippedbarbs may be made of varying sizes designed for specific surgicalapplications. For joining fat and relatively soft tissues, larger barbsmay be desired, whereas smaller barbs may be more suitable forcollagen-dense tissues. In some embodiments, a combination of large andsmall barbs within the same structure may be beneficial, for examplewhen a suture is used in tissue repair with differing layer structures.Use of the combination of large and small barbs with the same suturewherein barb sizes are customized for each tissue layer will ensuremaximum anchoring properties. In particular embodiments, a singledirectional suture may have both large and small barbs; in otherembodiments a bi-directional suture may have both large and small barbs.Barbs 630 may include geometrical shapes such as round, triangular,square, oblique, elliptical, octagonal, rectangular, and flat. In someembodiments, barbs 630 may be formed on loop 612 which allows movementof loop 612 through tissue in one direction but resists the withdrawalof suture 610 after loop 612 has been implanted in the tissue.

In embodiments, such as shown in FIG. 6, proximal end 613 a of firstsection 613 may be angled to form a tapered surface 617. Tapered surface617 angles downwardly towards proximal end 611 a of looped suture 610.Tapered surface 617 forms an angle a relative to a longitudinal axis “X”of second section 614, between zero degrees (0°) and ninety degrees(90°), and preferably between about five degrees (5°) to about sixtydegrees (60°). Tapered surface 617 facilitates insertion of loop 612into or through tissue. Tapered surface 617 may be formed prior to,during or following the joining of first and second sections 613, 614.In one embodiment, tapered surface 617 is formed during the weldingprocess using a die (not shown) having a cutting surface (not shown). Inanother embodiment, tapered surface 617 is formed by a blade (notshown). The blade used to form tapered surface 617 may be heated,ultrasonically vibrated or otherwise adapted to facilitate cutting ofthread 611. Tapered surface 617 of first section 613 may be formed suchthat joined segment 615 extends beyond first section 613 of elongatebody 611. In this manner, tapered surface 617 forms a smooth transitionwith second section 614 of elongate body 611.

Although shown having a substantially planar taper, tapered surface 617may include any number of configurations. For example, FIGS. 7A-9Cillustrate alternate embodiments, including a beveled tapered surface717 a (FIGS. 7A-7C), a laterally and longitudinally concave taperedsurface 817 b (FIGS. 8A-8C), a laterally and longitudinally convextapered surface 917 c (FIGS. 9A-9C) or any combination thereof.Respective beveled, concave and convex tapered surfaces (collectively,contoured tapered surfaces 717, 817, 917, respectively) may be formed ina similar manner as planar tapered surface 617. That is, contouredtapered surfaces 717, 817, 917 may be formed during the welding processusing a die (not shown) having an appropriately shaped cutting surface(not shown). Alternatively, contoured tapered surfaces 717, 817, 917 maybe formed using a blade (not shown) having an appropriately shapedcutting surface. Tapered surface 617 may be selected depending on thetissue being sutured and/or the desired depth of penetration of loop 612within the tissue.

In some embodiments, the proximal end of the overlapping first sectionmay be perpendicular to the second overlapping section of the suture(see FIG. 5). In still other embodiments, the proximal end of theoverlapping first section may form an angle which is greater than ninetydegrees, wherein the polymeric coating may be applied in a manner whichcreates a tapered polymeric coating (see FIG. 4).

When fabricated from a degradable material, the sutures described hereinmaintain their structural integrity after implantation for apredetermined period of time, depending on the characteristics of theparticular copolymer used. Such characteristics include, for example,the components of the copolymer, including both the monomers utilized toform the copolymer and any additives thereto, as well as the processingconditions (e.g., rate of copolymerization reaction, temperature forreaction, pressure, etc.), and any further treatment of the resultingcopolymers, i.e., coating, sterilization, etc. The manufacturingparameters involved in the forming of the loop also affect the rate atwhich the suture is absorbed. The joint may absorb at a different ratefrom the remainder of the suture.

The formation of barbs on a suture body may be utilized to change thedegradation time of the suture as described in U.S. patent applicationSer. No. 11/556,002 filed on Nov. 2, 2006, entitled “Long TermBioabsorbable Barbed Sutures”, the entire contents of which areincorporated by reference herein.

In some embodiments, at least one bioactive agent may be combined withthe sutures described herein. For example, a bioactive agent may becombined with the polymer used to form the suture, and/or a bioactiveagent may be combined with the polymeric coating. The at least one agentmay be freely released by the suture or may be chemically bound to thesurface of the suture.

Suitable bioactive agents include, for example, biocidal agents,antimicrobial agents, antibiotics, anti-proliferatives, medicants,growth factors, anti-clotting agents, clotting agents, analgesics,anesthetics, anti-inflammatory agents, wound repair agents and the like,chemotherapeutics, biologics, protein therapeutics, monoclonal orpolyclonal antibodies, DNA, RNA, peptides, polysaccharides, lectins,lipids, probiotics, diagnostic agents, angiogenics, anti-angiogenicdrugs, polymeric drugs, and combinations thereof.

Bioactive agents include substances which are beneficial and tend topromote the healing process. For example, the looped sutures can beprovided with a bioactive agent that will be deposited at the suturedsite. The bioactive agent can be chosen for its antimicrobialproperties, capability for promoting wound repair and/or tissue growth,or for specific indications such as thrombosis. In embodiments,combinations of such agents may be applied to the medical device of thepresent disclosure before, during, or after formation of barbs.

The term “antimicrobial agent” as used herein includes an agent which byitself or through assisting the immune system, helps the body destroy orresist microorganisms which may be pathogenic. An antimicrobial agentincludes antibiotics, antiseptics, quorum sensing blockers, antifungals,anti-virals, surfactants, metal ions, antimicrobial proteins andpeptides, antimicrobial polysaccharides, disinfectants and combinationsthereof. Antimicrobial agents which are slowly released into the tissuecan be applied in this manner to aid in combating clinical andsub-clinical infections in a surgical or trauma wound site. Inembodiments, suitable antimicrobial agents may be soluble in one or moresolvents.

In embodiments, the following bioactive agents may be used alone or incombination with other bioactive agents described herein: ananthracycline, doxorubicin, mitoxantrone, a fluoropyrimidine, a folicacid antagonist, methotrexate, mitoxantrone, quorum sensing blocker,brominated or halogenated furanones, a podophylotoxin, etoposide,camptothecin, a hydroxyurea, a platinum complex, cisplatin, doxycycline,metronidazole, trimethoprim-sulfamethoxazole, rifamycins like rifampin,a fourth generation penicillin (e.g., a ureidopenicillin acarboxypenicillin, meziocillin, piperacillin, carbenicillin, andticarcillin, and an analogue or derivative thereof), a first generationcephalosporin (e.g., cephazolin sodium, cephalexin, cefazolin,cephapirin, and cephalothin), a carboxypenicillin (e.g., ticarcillin), asecond generation cephalosporin (e.g., cefuroxime, cefotetan, andcefoxitin), a third generation cephalosporin (e.g., naxcel, cefdinir,cefoperazone, ceftazidime, ceftriaxone, and cefotaxime), polyvinylpyrrolidone (PVP), a fourth generation cephalosporin (e.g., cefepime), amonobactam (e.g., aztreonam), a carbapenem (e.g., imipenem, ertapenemand meropenem), an aminoglycoside (e.g., streptomycin, gentamicin,tobramycin, and amikacin), an MSL group member (e.g., a macrolide, along acting macrolide, a lincosamide, a streptogramin, erythromycin,azithromycin, clindamycin, syneroid, clarithromycin, and kanamycinsulfate), tetracyclines like minocycline, fusidic acid, trimethoprim,metronidazole; a quinolone (e.g., ciprofloxacin, ofloxacin,gatifloxacin, moxifloxacin, levofloxacin, and trovafloxacin), a DNAsynthesis inhibitor (e.g., metronidazole), a sulfonamide (e.g.sulfamethoxazole, trimethoprim, including cefixime, spectinomycin,tetracycline, nitrofurantoin, polymyxin B, and neomycin sulfate),beta-lactam inhibitors like sulbactam, chloramphenicol, glycopeptideslike vancomycin, mupirocin, polyenes like amphotericin B, azoles likefluconazole, and other known antimicrobial agent known in the art.

Other suitable bioactive agents include one or more of the following: afibrosing agent that promotes cell regeneration, a fibrosing agent thatpromotes angiogenesis, a fibrosing agent that promotes fibroblastmigration, a fibrosing agent that promotes fibroblast proliferation, afibrosing agent that promotes deposition of extracellular matrix, afibrosing agent that promotes tissue remodeling, a fibrosing agent thatis a diverticular wall irritant, silk (such as silkworm silk, spidersilk, recombinant silk, raw silk, hydrolyzed silk, acid-treated silk,and acylated silk), talc, chitosan, bleomycin or an analogue orderivative thereof, connective tissue growth factor (CTGF), metallicberyllium or an oxide thereof, copper, saracin, silica, crystallinesilicates, quartz dust, talcum powder, ethanol, a component ofextracellular matrix, oxidized cellulose, polysaccharides, collagen,fibrin, fibrinogen, poly(ethylene terephthalate),poly(ethylene-co-vinylacetate), N-carboxybutylchitosan, an RGD protein,a polymer of vinyl chloride, cyanoacrylate, crosslinked poly(ethyleneglycol)-methylated collagen, an inflammatory cytokine, TGFβ, PDGF, VEGF,TNFα, NGF, GM-CSF, IGF-α, IL-1, IL-8, IL-6, a growth hormone, a bonemorphogenic protein, a cell proliferative agent, dexamethasone,isotretinoin, 17-β-estradiol, estradiol, diethylstibesterol,cyclosporine a, all-trans retinoic acid or an analogue or derivativethereof, wool (including animal wool, wood wool, and mineral wool),cotton, bFGF, polyurethane, polytetrafluoroethylene, activin,angiopoietin, insulin-like growth factor (IGF), hepatocyte growth factor(HGF), a colony-stimulating factor (CSF), erythropoietin, an interferon,endothelin-1, angiotensin II, bromocriptine, methylsergide, fibrosin,fibrin, an adhesive glycoprotein, proteoglycan, hyaluronan, secretedprotein acidic and rich in cysteine (SPaRC), a thrombospondin, tenacin,a cell adhesion molecule, dextran based particles, an inhibitor ofmatrix metalloproteinase, magainin, tissue or kidney plasminogenactivator, a tissue inhibitor of matrix metalloproteinase, carbontetrachloride, thioacetamide, superoxide dismutase to scavengetissue-damaging free radicals, tumor necrosis factor for cancer therapy,colony stimulating factor, interferon, interleukin-2 or otherlymphokines to enhance the immune system, platelet rich plasma,thrombin, peptides such as self assembly peptide systems, amino acidssuch as radA based amino acids, hydrogels such as super absorbinghydrogel materials, combinations thereof, and so forth.

A wide variety of anti-angiogenic factors may be readily utilized withinthe context of the present disclosure. Representative examples includeAnti-Invasive Factor; retinoic acid and derivatives thereof; paclitaxela highly derivatized diterpenoid; Suramin; Tissue Inhibitor ofMetalloproteinase-1; Tissue Inhibitor of Metalloproteinase-2;Plasminogen Activator Inhibitor-1; Plasminogen Activator Inhibitor-2;various forms of the lighter “d group” transition metals such as, forexample, vanadium, molybdenum, tungsten, titanium, niobium, and tantalumspecies and complexes thereof; Platelet Factor 4; Protamine Sulphate(Clupeine); Sulphated Chitin Derivatives (prepared from queen crabshells); Sulphated Polysaccharide Peptidoglycan Complex (SP-PG) (thefunction of this compound may be enhanced by the presence of steroidssuch as estrogen, and tamoxifen citrate); Staurosporine; Modulators ofMatrix Metabolism, including for example, proline analogs{[(L-azetidine-2-carboxylic acid (LACA), cishydroxyproIine,d,L-3,4-dehydroproline, Thiaproline, α,α-dipyridyl, β-aminopropionitrilefumarate; MDL 27032 (4-propyl-5-(4-pyridinyl)-2(3H)-oxazolone;Methotrexate; Mitoxantrone; Heparin; Interferons; 2 Macroglobulin-serum;ChIMP-3; Chymostatin; β-Cyclodextrin Tetradecasulfate; Eponemycin;Camptothecin; Fumagillin Gold Sodium Thiomalate (“GST”); D-Penicillamine(“CDPT”); β-1-anticollagenase-serum; α2-antiplasmin; Bisantrene;Lobenzarit disodium (N-(2)-carboxyphenyl-4-chloroanthronilic aciddisodium or “CCA”; Thalidomide; Angostatic steroid; AGM-1470;carboxynaminolmidazole; metalloproteinase inhibitors such as BB94,analogues and derivatives thereof, and combinations thereof.

A wide variety of polymeric drugs may be readily utilized within thecontext of the present disclosure. Representative examples includesteroidal anti-inflammatory agents, non-steroidal anti-inflammatoryagents, and combinations thereof. Examples of the non-steroidalanti-inflammatory agent which may be used with the present disclosureare aspirin, indomethacin, ibuprofen, phenylbutazone, diflusinal, andcombinations thereof.

Examples of the steroidal anti-inflammatory agent which may be used areglucocorticoids such as cortisone and hydrocortisone, betamethasone,dexamethasone, fluprednisolone, prednisone, methylprednisolone,prednisolone, triamcinolone, paramethasone, and combinations thereof.

Although the above bioactive agents have been provided for the purposesof illustration, it should be understood that the present disclosure isnot so limited. In particular, although certain bioactive agents arespecifically referred to above, the present disclosure should beunderstood to include analogues, derivatives and conjugates of suchagents.

The looped sutures and/or polymeric coatings may also include, forexample, biologically acceptable plasticizers, antioxidants andcolorants, and other optional ingredients.

Bioactive agents may be applied onto the suture and/or the polymericcoating utilizing any method within the purview of one skilled in theart including, for example, spraying, dipping, brushing, rolling,wiping, painting, extruding, ultrasonics, and the like. In embodiments,a bioactive agent may be deposited within the barb angles, that is, theangle formed between the barbs and the elongate body of the sutures.This placement of the bioactive agent between the barbs and the elongatebody of the sutures places the bioactive agent at precisely definedlocations within a tissue wound closure, which thereby provides a uniquecontrolled and sustained release dosage form.

The sutures may be dyed in order to increase the visibility of thesuture in the surgical field. Any dye suitable for incorporation inmedical devices may be used. Such dyes include, but are not limited to,carbon black, bone black, D&C Green No. 6, and D&C Violet No. 2.Filaments in accordance with the present disclosure may be dyed byadding dye in an amount up to about a few percent; in other embodiments,they may be dyed by adding dye in an amount of about 0.2%; in stillfurther embodiments, the dye may be added in an amount from about 0.06%to about 0.08%.

In use, the looped sutures described herein may include a needle (notshown) on the proximal end thereof. The needle is inserted into andthrough a first and second flap of tissue. The looped suture may bepulled through the tissue until the proximal end of the firstoverlapping section contacts the tissue. Once a portion of the loop ofthe suture is received within the tissue, the proximal end of the suturemay be inserted through the loop. The proximal end of the suture maythen be pulled tight, thereby approximating the first and second tissueflaps towards one another. The proximal end of the suture may then beknotted or otherwise secured to the loop. In one embodiment, a knot maybe formed in the proximal end to prevent the proximal end fromwithdrawing from the loop. In another embodiment, the proximal end ofthe suture may be tied directly to the loop.

EXAMPLE 1

A study was performed on 60 coated and uncoated looped sutures. Bothsterilized and non-sterilized versions of the coated and uncoated loopedsutures were equally tested.

Each of the looped sutures were made from apoly(glycolide-co-trimethylene carbonate) with the first and secondoverlapping portions of the looped suture ultrasonically welded to formthe joint.

Thirty of the looped sutures remained uncoated and thirty of the loopedsutures were dip-coated in a 5% solution ofpoly(glycolide-co-trimethylene carbonate) and allowed to dry. Thedip-coated looped sutures included a web which span the distal apertureof the loop. The web was solid and not punctured.

Half of the coated and uncoated looped sutures were sterilized creatingthe following four groups: 15 uncoated, non-sterilized looped sutures;15 uncoated, sterilized looped sutures; 15 coated non-sterilized loopedsutures; and 15 coated, sterilized looped sutures.

Each of the four groups were immersed in a buffer solution andmaintained at a temperature of 50° C. to determine the amount of timeneeded for the looped suture to open and the overlapping sections tobecome unattached. The results are provided in Table-I below:

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to those preciseembodiments, and that various other changes and modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the disclosure.

1-10. (canceled)
 11. A suture comprising: an elongate body including aproximal section and a distal section, the distal section including afirst section overlapping a second section, a loop, and a distalaperture defined within the loop; and a polymeric coating positioned ononly a portion of the loop and a portion of the first sectionoverlapping the second section.
 12. The suture of claim 11, wherein theelongate body comprises a biocompatible material.
 13. The suture ofclaim 11, wherein the first and second sections are secured together byat least one method selected from the group consisting of glues,adhesives, solvents, heat, and ultrasonic energy.
 14. The suture ofclaim 11, wherein the first and second sections are secured together byultrasonic energy.
 15. The suture of claim 11, wherein the first sectionfurther comprises a tapered end.
 16. The suture of claim 11, wherein thepolymeric coating comprises a material selected from the groupconsisting of polylactic acids, polyglycolic acids,polylactide-co-glycolide copolymers, polytrimethylene carbonate,poly--caprolactone, poly-dioxanone, polyhydroxyalkanoates,polyphosphasenes, polypropylene fumarates, polyanhydrides,polyorthoesters, polyimides, polyurethanes, polyurethaneureas,perfluoroalkoxy polymers, florinated ethylene/propylene copolymers,polyanhydride esters, polysaccharides, polyethylene-lactone copolymers,polyethylene-polyorthoester copolymers, polymer drugs, hydrophilic vinylpolymers, phosphoryl cholines, hydroxamates, vinyl furanones,quarternary ammoniums, alkylene oxides, collagen, elastin, keratin,fibrin, and blends, copolymers, homopolymers, and combinations thereof.17. The suture of claim 11, wherein the polymeric coating comprisescopolymers of poly(glycolide-co-trimethylene carbonate).
 18. The sutureof claim 11, wherein the distal aperture defined within the loop allowsthe proximal section to pass through the distal aperture without passingthrough the polymeric coating.
 19. The suture of claim 11, wherein thesuture comprises a monofilament suture.
 20. The suture of claim 11,wherein the tapered end of the first section angles downwardly towardsthe proximal section of the elongate body.
 21. The suture of claim 11,wherein the polymeric coating is positioned across a portion of thedistal aperture.
 22. The suture of claim 21, wherein the polymericcoating positioned across a portion of the distal aperture comprises afilm.
 23. The suture of claim 21, wherein the polymeric coatingpositioned across a portion of the distal aperture comprises a web. 24.The suture of claim 21, wherein the polymeric coating positioned acrossa portion of the distal aperture is distal to, and in spaced relationfrom, the first section and the second section to reinforce the loop.